09.15.14
Minneapolis, Minn.-based Nonin Medical Inc., a manufacturer of non-invasive medical monitoring, has gained U.S. Food and Drug Administration 510(k) clearance for its Nonin Model 3231 OEM/eHealth finger pulse oximeter. The finger pulse oximeter plugs into a telemedicine hub or kiosk through a USB connector and measures oxygen saturation and pulse rate in pediatric to adult patients. The Model 3231 received the CE mark last year.
“Leading telemedicine providers such as HealthSpot and Bosch Healthcare have chosen to integrate the Nonin 3231 into their telehealth systems because they expect the 3231 to provide superior performance in the widest patient population, including challenging patients,” said Mark VanderWerf, vice president of eHealth and OEM business for Nonin Medical.
“Unlike some imported oximeters, Nonin’s American-made Model 3231 is a medical device with clinically proven accuracy, not a health and wellness gadget,” VanderWerf said. “This is important to telemedicine providers because they are measuring and guiding decisions on real patients with real diagnosed diseases such as COPD, CHF and asthma. They depend on the clinical accuracy of a real medical device,” VanderWerf said.
The Model 3231 features Nonin’s PureSAT pulse Oximetry (SpO2) technology, which uses intelligent pulse-by-pulse filtering to provide precise oximetry measurements—including in the presence of motion, dark skin tones, low perfusion, rapid SpO2 changes and other challenging conditions. PureSAT automatically adjusts to each patient's condition to provide fast and reliable readings that clinicians can act on. It also features Correctcheck technology, which provides feedback via a digital display if the patient's finger is not placed correctly in the device. Finally Smartpoint capture, an algorithm developed by Nonin, that automatically determines when a high quality measurement is ready to be stored.
“Leading telemedicine providers such as HealthSpot and Bosch Healthcare have chosen to integrate the Nonin 3231 into their telehealth systems because they expect the 3231 to provide superior performance in the widest patient population, including challenging patients,” said Mark VanderWerf, vice president of eHealth and OEM business for Nonin Medical.
“Unlike some imported oximeters, Nonin’s American-made Model 3231 is a medical device with clinically proven accuracy, not a health and wellness gadget,” VanderWerf said. “This is important to telemedicine providers because they are measuring and guiding decisions on real patients with real diagnosed diseases such as COPD, CHF and asthma. They depend on the clinical accuracy of a real medical device,” VanderWerf said.
The Model 3231 features Nonin’s PureSAT pulse Oximetry (SpO2) technology, which uses intelligent pulse-by-pulse filtering to provide precise oximetry measurements—including in the presence of motion, dark skin tones, low perfusion, rapid SpO2 changes and other challenging conditions. PureSAT automatically adjusts to each patient's condition to provide fast and reliable readings that clinicians can act on. It also features Correctcheck technology, which provides feedback via a digital display if the patient's finger is not placed correctly in the device. Finally Smartpoint capture, an algorithm developed by Nonin, that automatically determines when a high quality measurement is ready to be stored.